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Supplier Management Solutions

Supplier Management Solutions Critical to Quality Management

Manufacturers are becoming increasingly aware that supplier management solutions are critical to the quality management process. Major companies are making the move to automated solutions that help control the end-to-end supplier lifecycle. This is critical to quality management because an effective supplier management solution can monitor supplier parts issues, identify risk, and help evaluate supplier performance.

Supplier Management Solutions Monitor Supply Issues

Vendors providing goods and services to companies doing business in regulated environments are only qualified to supply specific products and services. Companies must monitor how their vendors are performing using information from audits, non-conformance reports, supplier deviations and CAPAs. Tracking these issues using spreadsheets can become an administrative nightmare; an automated supplier management solution can simplify identifying vendor quality issues.

Identify Risky Vendor Situations Using Supplier Management Solutions

With a small number of vendors, it's a fairly simply task to track who is performing well and which vendor to cull from the approved vendor list. As a business grows and becomes more reliant on external vendors, they become more exposed to delivery disruption, vendor bankruptcy and supply shortages. FDA reports the most commonly identified deficiencies in supplier management solutions include:

The Pharma Consulting Blog reports that FDA Commissioner Dr. Margaret A. Hamburg has stated that under her leadership, "the industry can expect to see a more aggressive posture with respect to enforcement. It is expected that the FDA will be provided additional funding to support the enforcement. For this reason, it is believed that companies who manufacture, import and distribute FDA-regulated products will be visited more often by the FDA."

This means the FDA will focus heavily on supply chain management and companies should be developing strong supplier management solutions.

Vendors providing goods and services to companies doing business in regulated environments are only qualified to supply specific products and services. As such, these suppliers must be accurately tracked on a company's approved vendor list (AVL). The AVL must be continually managed and monitored, a complex supplier management system that becomes exponentially more difficult as product designs and manufacturing processes change over time. Further complexities arise as increasing numbers of suppliers interface with or are managed by different departments and divisions across the company.

With MasterControl supplier management software, all supplier management statuses and quality information (such as nonconforming material reports) is automatically contained in a single, easy to access location. In addition to providing an easily maintainable AVL, MasterControl Supplier features a user-friendly interface for accessing all documentation and records related to each supplier.

With MasterControl's supplier management solution, goods or services can be added to the "approved to supply" list simply by linking the goods/services to a specific supplier in MasterControl. Suppliers, conversely, can be added the same way. If a part is linked to a supplier that is not approved, the link will be disabled until the supplier becomes approved or reapproved. All of this information is easily obtainable via MasterControl's built-in reporting tool.

MasterControl's Web-based platform makes accessing supplier data easy and efficient. Geographically dispersed divisions have the ability to share supplier qualification data with others in the corporation, potentially cutting out costly duplication of effort and speeding time to market.

The QMS Provider for the FDA

MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.